POS0494 DEVELOPMENT AND VALIDATION OF A QUESTIONNAIRE FOR PRE-ROMOSOZUMAB THERAPY SCREENING
Authors: Y. El Miedany, M. Toth, M. Elgaafary, S. Bahlas, M. Elwy, S. A. Mahran, M. H. Abu-Zaid, S. A. A. Tabra, W. Elwakil
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Romosozumab has expanded the osteoporosis management options in postmenopausal women who are at very high risk of fracture. Romosozumab has dual mechanism of action as it modulates both bone formation and bone resorption and aims to achieve optimal fracture prevention. While Romosozumab appears to have a generally manageable tolerability profile, extra clinical experience is required to, more definitively, establish its efficacy and safety. Romosozumab is contraindicated in patients with past history of myocardial infarction and stroke. Currently there is no tool to screen osteoporosis patients for Romosozumab contraindications. <h3>Objectives</h3> To develop a questionnaire for pre-Romosozumab therapy screening for use in standard clinical practice. <h3>Methods</h3> The Pre-Romosozumab screening questionnaire was conceptualized based on frameworks used by the WHO Quality of Life tool and the PROMIS. Initially, review of the literature and cognitive interviews held with physicians with special interest in bone health, patients, osteoporosis nurses, and outpatient managers were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. The questionnaire included 5 main categories which are patient-centred: 1. Patient's anthropometric measures, 2. items specifically linked to Romosozumab indications and contraindications, 3. Self-completed Fracture risk assessment, 4. Current medication(s), 5. Comorbidities. The answers to the questions were compared to the patients' notes. Comprehensibility was assessed using numerical visual analogue scale [0-10]. <h3>Results</h3> The developed questionnaire is composed of 2-pages. Page-1 to be self-completed by the patient to screen for any possible contraindication to Romosozumab therapy, current medications, and comorbidities. Page-2 is to be completed by the treating health care professional and it includes information of how this patient meets the prescribing recommendations for Romosozumab. The primary screening questionnaire contained 15 items; all met the minimum acceptable value of 0.81 for item-level content validity index. Using exploratory factor analysis (EFA), four factors (intrapersonal-psychological, intrapersonal-cognitive, provider-related, and socio-economic reasons) were assessed, and Cronbach's alpha coefficient of 0.79, 0.86, 0.79, and 0.81, respectively, were identified. The reliability of the questionnaire (r = 0.88) was confirmed. The questionnaire showed also a high degree of comprehensibility (9.6). <h3>Conclusion</h3> The questionnaire is a valid and reliable instrument that can be used in standard practice to pre-screen patients identified as candidates for Romosozumab therapy. The questionnaire achieved high degree of comprehensibility. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.